Alfapump-albumin Replacement Therapy
关键词
抽象
描述
The study will be a single centre, open-label trial. The patients will have a diagnosis of refractory ascites and will meet specified inclusion/exclusion criteria Informed consent will be obtained from all patients. All patients will have an alfapump surgically inserted and in addition will receive 8g of salt-poor Human Albumin Solution (20%) per 1 litre of Ascites drained. This Intravenous administration will be intermittent (every 2 weeks) and will take place as a day patient. Patients will also receive standard of care, which may include, but is not limited to, administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
The primary objective of the study is to assess whether intermittent human albumin replacement in accordance with large volume paracentesis guidelines (8g/L ascites drained) can prevent the development of renal dysfunction at the 3-month assessment. This would potentially guide the clinical use of the alfapump system.
The secondary objectives of the study are to address the objectives of a previous alfa pump study /sub study, to allow comparison of the proposed study data to that generated in the previous studies. These will be measured at the 1-month and 3-month time points.
日期
| 最后验证: | 03/31/2018 |
| 首次提交: | 04/29/2015 |
| 提交的预估入学人数: | 05/13/2015 |
| 首次发布: | 05/18/2015 |
| 上次提交的更新: | 04/04/2018 |
| 最近更新发布: | 04/08/2018 |
| 实际学习开始日期: | 12/31/2015 |
| 预计主要完成日期: | 11/30/2017 |
| 预计完成日期: | 11/30/2017 |
状况或疾病
干预/治疗
Device: alfapump with albumin treatment
Drug: alfapump with albumin treatment
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: alfapump with albumin treatment patients implanted with an alfapump, receiving intermittent salt-poor Human Albumin solution treatment | Device: alfapump with albumin treatment Implantation of alfapump |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Males and non-pregnant females (determined by serum pregnancy test) ≥ 18 years of age. Women of childbearing age must be prepared to use at least 1 effective (≤1% failure rate) method of contraception during the course of the study 2. Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria 3. Presenting with refractory ascites* and requiring periodic large volume paracentesis (large volume defined as ≥ 5 L to accord with the clinical guidance of EASL, European Association for the Study of the Liver, which recommends withdrawal of 5 L should precipitate administration of albumin). 4. Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device Exclusion Criteria: 1. Gastrointestinal haemorrhage over the last 7 days 2. Renal failure defined as serum creatinine higher than or equal to 2 mg/dl 3. Severe coagulopathy defined as prothrombin time greater than 40% more than Upper Limit of Normal 4. Platelet count of less than 40,000 / μL unless platelet therapy is given at the time of surgery 5. Clinical Evidence of recurrent bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks 6. Clinical evidence of recurrent urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks 7. Clinical evidence of loculated ascites 8. Advanced hepatocellular carcinoma, defined as exceeding Milan criteria 9. Obstructive uropathy, residual urinary volume exceeding 100ml, or any bladder anomaly which might contraindicate implantation of the device 10. Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to cardiac pacemaker or cardiovertering defibrillator 11. Pregnant females or females anticipating pregnancy during study period 12. Patients currently enrolled in another interventional clinical study 13. Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure) 14. Known presence of human immunodeficiency virus (HIV) 15. Immuno-modulatory treatment (including azathioprine, methotrexate, anti-TNF therapies) used within last 4 months 16. Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years 17. BMI>40 presenting a risk for surgery and tunnelled lines 18. Patients with contraindications for general anesthesia |
结果
主要结果指标
1. To assess whether intermittent human albumin replacement in accordance with large volume paracentesis guidelines (8g/L ascites drained) can prevent the development of renal dysfunction, measured by serum creatinine [3 months]
次要成果指标
1. Assessment of circulatory haemodynamics, measured by non-invasive cardiac haemodynamics [3 months]
2. Assessment of cirrhosis- related complications, measured by Incidence of specific cirrhosis-related complications [3 months]
3. Assessment of the Overall Survival at 3 months, measured by survival [3 months]
4. Assessment of impact on nutrition, measured by changes in body weight [3 months]
5. Assessment of impact on nutrition, measured by changes in circumference of arm [3 months]
6. Assessment of impact on nutrition, measured by changes in tricipital skinfold [3 months]
7. Assessment of impact on nutrition, measured by changes in handgrip [3 months]
8. Assessment of the need for large volume paracentesis, measured by the overall requirements of paracentesis [3 months]
9. Assessment of impact on Systemic Inflammatory Response, measured by CRP [3 months]
10. Assessment of impact on Systemic Inflammatory Response, measured by cytokines [3 months]
11. Assessment of impact on Systemic Inflammatory Response, measured by function of the peripheral blood mononuclear cells [3 months]
12. Assessment of levels of bacterial DNA in serum, measured by presence of bacterial DNA in blood [3 months]
